[Federal Register Volume 71, Number 25 (Tuesday, February 7, 2006)]
[Notices]
[Page 6284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1588]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0045]


Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid 
Testing; Public Workshop; Request for Comments

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop; request for comments.

-----------------------------------------------------------------------

    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Behavior-Based Blood Donor Deferrals in the Era of 
Nucleic Acid Testing (NAT).'' The purpose of the public workshop is to 
address regulatory and scientific challenges and opportunities in the 
development of policy concerning protection of the blood supply from 
transfusion-transmissible diseases by deferring blood donors based on 
high-risk behavior, and to request comments on this topic.
    Date and Time: The public workshop will be held on March 8, 2006, 
from 8 a.m. to 5:30 p.m. The deadline for registration via mail, fax, 
or e-mail is February 17, 2006 (see Registration). Written or 
electronic comments will be accepted until May 8, 2006 (see Comments).
    Addresses: The public workshop will be held at the National 
Institutes of Health, Lister Hill Auditorium, Bldg. 38A, 8600 Rockville 
Pike, Bethesda, MD 20894. Submit written comments to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments.
    Contact Person: Rhonda Dawson, Center for Biologics Evaluation and 
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-6129, FAX: 301-827-2843, e-mail: 
[email protected].
    Registration: Mail, fax, or e-mail your registration information 
(including name, title, firm name, address, and telephone and fax 
numbers) to Rhonda Dawson (see Contact Person) by February 17, 2006. 
There is no registration fee for the public workshop. Early 
registration is recommended because seating is limited. Registration on 
the day of the public workshop will be provided on a space-available 
basis beginning at 7:15 a.m.
    If you need special accommodations due to a disability, please 
contact Rhonda Dawson (see Contact Person) at least 7 days in advance.
    Comments: Regardless of attendance at the public workshop, 
interested persons may submit to the Division of Dockets Management 
(see Addresses) written or electronic comments regarding the public 
workshop. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

SUPPLEMENTARY INFORMATION: The purpose of the public workshop is to 
address regulatory and scientific challenges and opportunities in the 
development of policy concerning protection of the blood supply from 
transfusion-transmissible diseases by deferring blood donors based on 
high-risk behavior. The public workshop will feature presentations by 
national and international experts from government and academic 
institutions and industry. The following discussions will be included:
     Current practices in the United States and in foreign 
countries regarding blood donor deferrals based on high-risk behavior,
     Comparison of selected tissue donor deferral policies to 
blood donor deferral policies,
     Behavioral risks for transfusion-transmitted diseases,
     Residual risks of infection from transfusion, and
     Potential alternative approaches to donor screening and 
testing.
    Transcripts: Transcripts of the public workshop may be requested in 
writing from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 15 working days after the public workshop at a cost of 10 
cents per page. A transcript of the public workshop will be available 
on the Internet at http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: January 31, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1588 Filed 2-6-06; 8:45 am]
BILLING CODE 4160-01-S